MAUDE Adverse Event Report: B BRAUN MEDICAL B BRAUN ECLIPSE ELASTOMERIC PUMP; ECLIPSE PUMP

Model Number E102000

Device Problem Failure to Infuse (2340)

Patient Problem Missed Dose (2561)

Event Date 04/23/2014

Event Type  Other  

Event Description

On (b)64), eclipse pump would not infuse for pt, though all clamps were open and filter was working.Our on-call rn went to pt's home and verified that it was not infusing.Our staff looked at it on (b)(6) and it was not moving / infusing.

• Brand Name: B BRAUN ECLIPSE ELASTOMERIC PUMP
• Type of Device: ECLIPSE PUMP
• Manufacturer (Section D): B BRAUN MEDICAL; 824 12th ave; bethlehem PA 18018 352
• MDR Report Key: 3787299
• MDR Text Key: 4431900
• Report Number: MW5035856
• Device Sequence Number: 1
• Product Code: MEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: E102000
• Device Lot Number: 0201305820
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 82